EP3849625A1 - Système pour analyser des fluides d'origine corporelle ou des fluides en contact avec le corps - Google Patents

Système pour analyser des fluides d'origine corporelle ou des fluides en contact avec le corps

Info

Publication number
EP3849625A1
EP3849625A1 EP19769417.7A EP19769417A EP3849625A1 EP 3849625 A1 EP3849625 A1 EP 3849625A1 EP 19769417 A EP19769417 A EP 19769417A EP 3849625 A1 EP3849625 A1 EP 3849625A1
Authority
EP
European Patent Office
Prior art keywords
liquid
line
fluid
collection
bag
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19769417.7A
Other languages
German (de)
English (en)
Inventor
Waldemar Janik
Franco Teltow
Anne Zygmanowski
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP3849625A1 publication Critical patent/EP3849625A1/fr
Pending legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/22—Fuels; Explosives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/1032—Determining colour for diagnostic purposes
    • A61B5/1034—Determining colour for diagnostic purposes by means of colour cards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150366—Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/207—Sensing devices adapted to collect urine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • A61M1/1609—Physical characteristics of the dialysate fluid after use, i.e. downstream of dialyser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/69—Drainage containers not being adapted for subjection to vacuum, e.g. bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3324—PH measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code

Definitions

  • the invention relates to a system for analyzing liquids originating from the body with a volume through which the liquid flows, in particular with a liquid line and / or a liquid storage volume, and a system that is integrated in the system and can be connected or connected to the volume
  • Sensor unit for the detection of at least one analyte in the liquid and / or at least one parameter of the liquid. It also affects one
  • Removal device for taking samples of liquids originating from the body with a sample volume, a sensor unit with the
  • Sample volume is connected or connectable.
  • Permanent transurethral catheters are one of the most frequently used care utensils in everyday clinical practice. Due to possible flan tract infections, there is a need for regular monitoring.
  • a urine analysis can be carried out, for example, by immersing commercially available test strips in the urine in a test vessel. These test strips have test fields that change their color
  • Health status of the patient can be taken.
  • an analysis device for analyzing urine which can be connected to a urine collection container and has: a) a discrete test section for performing a colorimetric test, each test section being designed to carry out a different colorimetric test, b ) a color sensor for reading out the test section and for outputting an indication based on the presence of an analyte and c) an integrated circuit for obtaining a display of the color sensor and calculating a quantity of the analyte in the urine. Solutions of this type with optical sensors are generally quite complex and expensive and are therefore less suitable for day-to-day hospital use with limited costs.
  • WO 2018 058 077 A1 discloses a sensor connector for connecting a urine bag and a catheter in order to determine the pH value and a nitrite concentration, the connector being a hollow body which forms a passage for the urine and a first end for connecting to the catheter and has a second end for connection to the line of the urine bag, and a pH sensor connected to the connector as a hydrogel and / or a nitrite sensor with plasmonic nanoparticles for detecting bacteria in the urine flowing through the passage, the pH sensor reversibly provides a colorimetric change based on the pH of the urine, and the nitrite sensor provides a colorimetric change based on the nitrite concentration of the urine.
  • a disadvantage of this system is that an exchange of the connector requires an opening of the otherwise closed system, which involves the risk of germs entering the system or the catheter.
  • test vessels have been used to carry out analyzes using conventional test strips, into which a sample of urine from a urine bag is filled.
  • the test vessels disadvantageously represent a potential source of infection for the nursing staff.
  • urine can drip onto the floor, which must then be removed and adversely affect hygiene in the hospital.
  • Such a urine withdrawal which is currently common in everyday clinical practice, also involves a certain amount This means more work for the nursing staff. Due to time constraints, it is not uncommon that urine analysis does not take place and a possible infection of the patient is recognized too late.
  • Urine bags or tube systems that are already equipped with test fields have the disadvantage that they have to be replaced quite quickly after contact with liquid, since the test fields can usually only be used once.
  • the present invention is based on the object of eliminating the disadvantages mentioned above, in particular a device for analyzing from the body
  • this object is achieved by a system according to claim 1, in particular a system for analyzing liquids originating from the body with a volume through which the liquid flows, in particular with a
  • Liquid line and / or a liquid storage volume and an integrated in the system and connected to the volume or connectable
  • Sensor unit for the detection of at least one analyte of the liquid and / or at least one parameter of the liquid, wherein the sensor unit has or is a test strip with at least one test field, which is in the presence of an analyte to be recorded and / or as a function of a parameter to be recorded Liquid stains.
  • the task is also solved by a
  • Removal device in particular a removal device for taking samples of liquids originating from the body with a sample volume, a sensor unit being connected or connectable to the sample volume, the sensor unit having or being a test strip with at least one test field that is in the presence of an analyte to be detected and / or depending on a parameter of the liquid to be detected. Under a liquid coming from the body are next to direct
  • Body fluids such as urine, cerebrospinal fluid, tear fluid or aqueous humor
  • Nasal secretions sputum (saliva), pleural fluid, gastric juice, pancreatic secretions, bile, vaginal secretions, menstrual fluid, cervical mucus, amniotic fluid,
  • Parameters that can be determined with the aid of the system according to the invention include nitrite (this is formed by some germs from nitrate and therefore indicates a urinary tract infection), urobilinogen (arises from bilirubin and indicates as a breakdown product of hemoglobin to liver disease) ), Erythrocytes (indicate inflammation of the urinary tract), leukocytes (may occur if the kidney or bladder is inflamed), proteins (including albumin, in particular, indicate kidney disease), pH (an alkaline pH value occurs Urinary tract infections, an acidic pH value indicates diabetes), ketones (indicate increased fat loss in metabolic diseases), glucose (indicates diabetes and can also occur in some types of cancer), density (can include kidney disease) indicate if the density remains low despite low fluid intake), ascorbic acid (does not provide any information on the Health of the patient, but can measure other parameters
  • test strips with test fields that change their color in the presence of an analyte to be examined and its concentration are in particular in medical collecting bags and / or tubes or sample containers that can be opened or removed or connected, test strips with test fields that change their color in the presence of an analyte to be examined and its concentration.
  • the invention has the following advantages in particular.
  • Any bacterial infection of the patient can be quickly identified by rapid measurement (continuously, quasi-continuously or as required) and thus treated promptly
  • the liquid located in a separate sampling and testing device can be used for further analysis, so that additional sampling is not required
  • the liquid line is a catheter, a line tube for guiding body fluid into a collecting container, a bypass tube, a connector piece for connecting a catheter to a line tube or an extracorporeal blood line.
  • the liquid storage volume can in particular be a
  • the liquid line and / or the liquid storage volume can be designed or provided with a bypass in which the test strip is located. If necessary, liquid to be examined can be passed through the bypass so that the test strip
  • the bypass is exchangeably connected to the liquid line or to the liquid storage volume.
  • bypass with the test strip can be exchanged particularly easily without having to separate the catheter from the collecting bag.
  • the collection bag and catheter are connected to the patient over a longer period of time and the test strip has test fields with an irreversible color change property.
  • a bypass with integrated Test strips can also be part of a connector piece.
  • the bypass is preferably connected to an integrated test strip by penetrating a self-sealing membrane. This has the advantage that the bypass can be removed and replaced without leakage.
  • a further embodiment of the device is characterized in that the system comprises at least one sample container, one with which the
  • Liquid flow volume is connected or is connectable and in which the test strip is arranged.
  • the volume of the sample container is preferably not permanent, but is only filled with the liquid to be analyzed for the purpose of measurement or analysis. In this way, accidental contact of the
  • Test strip with liquid and premature consumption of the test strip can be avoided.
  • the sample container can preferably form a sample volume in which the test strip is arranged or to which the test strip is fluidly connected.
  • the sample volume can in particular be sealed off from the volume of the system through which liquid flows by means of a barrier.
  • the sample container can in particular be filled with a preferably isotonic solution.
  • the barrier can in particular be formed or arranged on the liquid storage volume and / or on the liquid line. Preferably that is
  • flowable volume can be fluidically connected. In this way, a measurement / analysis can be carried out in a particularly simple manner to one desired by medical personnel
  • the barrier is preferably a clamp
  • the sample container can consist of rigid, semi-rigid or flexible material. It is preferably arranged directly and immediately on a collection container or collection container for body fluid, in particular collection bags or collection bags for urine, blood, wound secretions or other.
  • the sample container can in particular be a bag, for example a tubular bag. Alternatively, it can be in the form of a protuberance of a liquid storage volume designed as a bag.
  • the sample container can be separated and removed from the volume through which liquid flows. This has the advantage that no new sampling is necessary if the
  • Liquid to be examined in the sample container is to be examined in more detail with an external analysis system.
  • a further embodiment of the invention is characterized in that the sample container is non-positively and / or positively and / or materially connected to the liquid storage volume or to the liquid line.
  • the sample container can be connected to or separated from the volume of the system through which liquid flows, in a particularly simple manner, which makes the system particularly user-friendly.
  • the sample container is designed as a syringe, in particular a single-use syringe, with a syringe cylinder and a syringe plunger that is movably received therein and limits a variable sample volume.
  • the object on which the present invention is based is achieved by a system for analyzing from the body
  • a fluid line and collecting device ie, a volume through which liquid flows
  • a liquid line in particular a hose
  • a liquid storage volume in particular a Liquid bag
  • a sensor unit connected or connectable to the fluid line and collection device for detecting at least one analyte in the liquid and / or at least one parameter of the liquid, which sensor unit has or is a test strip with at least one test field that is in Presence of an analyte to be detected and / or depending on a parameter to be detected of the liquid colors, furthermore with at least one attachment (with the sample container) that can be or is mounted fluidically and releasably on the fluid line and collection device, which serves as a carrier for the Sensor unit is formed.
  • a sampling device for taking samples of liquids originating from the body with a sample container, in which a sensor unit is arranged, which has or is a test strip with at least one test field, which can be detected in the presence of one
  • the removal device being designed as an attachment which is detachably mounted or mountable on a fluid line and collection device and fluidly connected or connectable thereto.
  • the cultivation is to be understood in particular in such a way that this one to the
  • Fluid line and collection device is a separate component.
  • the attachment is from the fluid line and collection device
  • Removable / detachable / removable / separable mounted or mountable on it that when removing / releasing / disassembling / separating the extension or when mounting it on or on the fluid line and collection device, operation or use of the fluid line and collection device is not or only slightly is impaired, ie, a liquid flow through or into the fluid line and collection device does not have to be interrupted in order to loosen or mount the attachment. That is, the
  • Fluid line and collection device is by mounting or loosening the
  • the attachment preferably has a single connection at which it connects to the fluid line and collection device is connectable or connected, or the attachment alternatively has exactly two connections in order to connect the attachment with both connections to the fluid line and collection device such that it can be flowed through in the manner of a bypass.
  • FIG. 1 is a schematic representation of a fluid system with a bag for collecting a body fluid with a test strip
  • FIG. 2 shows a schematic representation of a test strip of the system of FIG. 1,
  • FIG. 3 shows a schematic representation of a liquid system with a bag for collecting body fluid and a test strip arranged in a liquid line leading to the bag at different positions
  • Fig. 4 is a schematic representation of a fluid system with a bag for collecting body fluid and one in a connector
  • FIG. 5 shows a schematic representation of an alternative embodiment of a bag according to the invention
  • Fig. 6 shows a further alternative in a schematic representation
  • Fig. 7 shows a further alternative in a schematic representation
  • FIG. 8 shows a schematic representation of a device for extracorporeal blood treatment with a device according to the invention
  • FIG. 9 shows a schematic representation of a fluid system with a bag for collecting body fluid and a test strip arranged in a bypass.
  • FIG. 1 shows an example of a liquid system with a bag 1 for
  • the bag 1 can be designed as a collecting bag 1 or a collecting bag 1 and forms a liquid space 2, which can also be referred to as a collecting space 2, is provided with a drain valve 3 and via a flexible liquid line 4, here in the form of a hose 4 Connector piece 5 connected.
  • the connector piece 5 is connected to a catheter 6 on the side opposite the hose 4. In the present case, this can in particular be a transurethral
  • the catheter 6 although not shown in this way in the figure, can be in the form of a catheter 6 according to Nelaton, Tiemann, Mercier, Couvelaire, Dufouer, Frohmüller, Pezzer, Casper, Malecot and / or Stöer or modifications thereof.
  • the catheter 6 shown in FIG. 1 is a Foley catheter 6 and has a balloon 7 for fixation in the bladder of a patient.
  • a condom urinal is also conceivable and is within the scope of the invention.
  • Liquid can be drained from the liquid space 2 of the bag 1 via the drain valve 3.
  • the drain valve 3 arises at the lower edge of the bag 1 from the bag space 2, into which the hose 4 opens at the upper edge of the bag 1.
  • At least one sensor unit 100 in the form of a test strip 100 is arranged, in particular attached, in the bag space 2.
  • the test strip 100 has at least one test field 101-111 which changes its color in the presence of an analyte to be examined and / or its concentration.
  • Such a test strip 100 is shown by way of example in FIG. 2.
  • the test strip 100 shown in FIG. 2 has, for example, a test field 101 for determining the pFI value, a further test field 102 for determining nitrite, a further test field 103 for determining urobilinogen, a further test field 104 for determining erythrocytes, and a further test field 105 to determine
  • Leukocytes another test field 106 for the determination of proteins, another test field 107 for the determination of ketones, another test field 108 for the determination of glucose, a further test field 109 for determining ascorbic acid, a further test field 110 for displaying blood and a further test field 111 for
  • test fields are exemplary and in particular the number of test fields as well as the parameters detected by means of these can vary within the scope of the invention. In particular, only a part of these test fields on the
  • test strips or a redundant design are available.
  • FIG. 2 shows the test fields 101-111 on the test strip 100 in row form, but an arrangement of test fields 100 in matrix form is also within the scope of the invention.
  • a design of the test strip 100 in the form of a ring is within the scope of the invention.
  • This embodiment of the test strip 100 is particularly advantageous when the test strip 100 is in a cylindrical container.
  • Reference color chart can be used, with which it can be compared whether and if so in what concentration an analyte is present in the liquid to be examined. The same applies to the pFI value and the density of the liquid.
  • the reference color chart is preferably located in the vicinity of the test strip or is arranged in the vicinity of the test strip.
  • FIG. 3 shows a modified embodiment of the liquid system 1, which essentially corresponds to the embodiment according to FIG. 1, so that reference is made to the relevant description and only deviations are described below.
  • the liquid system 1 of FIG. 3 there are two
  • test strip 100 different positions for the test strip 100 are shown, of which only one or both can be provided with a test strip 100. Accordingly, a first test strip (100a) can be arranged in the liquid line 4, also here as a hose 4, between the bag 1 and the connector piece 5.
  • a second test strip 100b can be arranged directly on the catheter 6 itself.
  • a further embodiment not shown in the figures, has the test strip 100 in the bag 1, the first test strip 100a in the tube 4 and the second test strip 100b in the catheter 6.
  • a further embodiment is shown in FIG. 4, in which the test strip 100 is arranged on a connector / connector piece 5 or is integrated into the connector 5 as a component thereof. The connector 5 and thus also the test strip 100 are thus arranged between the tube 4 and the catheter 6.
  • An embodiment is advantageous in that conventional collecting bags 1 and catheters 6 can continue to be used.
  • the connector 5 can advantageously be designed as a separate consumable.
  • FIG. 5 A further embodiment, which enables medical personnel to carry out a quick measurement when required or, for example, when a bacterial infection is suspected, is shown in FIG. 5.
  • the collecting bag 1 is designed or equipped with sample containers 8a, 8b, 8c.
  • sample containers 8a, 8b, 8c In each of the
  • Sample containers 8a, 8b, 8c, a sensor unit 200 is arranged in the form of a test strip 200a, 200b, 200c, each with at least one test field.
  • Sample containers 8a, 8b, 8c can be made of rigid or semi-rigid or flexible
  • Be formed material and has a sample volume that compared to
  • Liquid space 2 of the bag 1 is sealed in a liquid-tight manner.
  • Liquid space in the form of a weld seam, peel seam, adhesive seam or the like. If necessary, the seal between the liquid space 2 and the respective sample volume of the sample containers 8a, 8b, 8c can be removed and a liquid connection can be formed, so that the sample volume is
  • Liquid space 2 is open and liquid to be examined can flow in
  • the bag 1 shown in FIG. 5 has three sample containers 8a, 8b, 8c on one side, each of which contains a test strip 200a, 200b, 200c, each with variable test fields.
  • the contents of the bag from the liquid space 2 can only get into one of the sample containers 8a, 8b, 8c when a fluidic connection has been brought about by an operator. Basically, one can stand out
  • sample container 8a, 8b, 8c on any side of the bag 1 and / or on the tube 4 and / or connector 5 and / or catheter 6.
  • Another embodiment, which is shown in FIG. 6, has a removable sample container 9. This has the advantage that no new sampling is necessary if the sample in the sample container is to be examined
  • FIG. 6 shows an example of a bag 1 with a bag space 2 or liquid space 2, an optional drain valve 3 and a connector unit 10.
  • a removable sample container 9 with an integrated test strip 200 is compatible with the connector unit 10 and can be attached to or with the Bag space 2 are connected.
  • the connection between the connector unit 10 and the sample container 9 can be non-positive and / or positive and / or material.
  • the connector unit 10 may advantageously have a rubber-elastic membrane. This can be pierced by the sample container 9 and effect a seal between the latter and the connector unit 10. After filling and removal of the sample container 9, the membrane can contract again due to its rubber-elastic properties and preferably seal the connector unit 10 independently, so that a
  • Connector unit 10 can be closed manually by means of a clamp, not shown in the figures.
  • the at least one connector unit 10 can be located at any point on the bag 1 and / or on the tube 4 and / or connector 5 and / or catheter 6.
  • FIG. 7 shows a further embodiment of the invention with a removable sample container with integrated test strip 200.
  • the sample container is designed here as a particularly connectable removal device in the form of a syringe with a piston 12 and a syringe cylinder 11. It can already be integrated in the bag 1 by the manufacturer, or it can only be connected to the bag 1 by the user before a sample is taken.
  • the removal device is or is connected to the liquid space 2 of the bag 1 by means of a preferably self-sealing connector unit 10. By pulling out the piston 12, liquid is sucked into the syringe barrel 11.
  • a test strip 200 is arranged in the syringe cylinder 11 and, depending on the presence of an analyte to be detected, the color of its changes at least one test field. It should be pointed out that in this embodiment the connector unit 10 can also be located at any point on the bag 1 and / or on the tube 4 and / or connector 5 and / or catheter 6.
  • FIG. 8 shows a simplified arrangement for extracorporeal blood treatment.
  • Blood is withdrawn from a patient 300 with the aid of a blood pump 302 and passed through an arterial blood line 301, here in the form of an arterial tube 301, into a dialyzer 303, where it is freed from excess water and substances that require urine and thus cleaned.
  • the blood travels back to the patient 300 via a venous blood line 304, here in the form of a venous tube 304.
  • the blood treatment machine 305 produces dialysis fluid for the duration of the therapy.
  • Dialysis fluid line / fluid line 306 flows counter to the blood direction and flows through the dialyzer 303 separately through a semipermeable membrane. Excess water and urinary substances are removed by the
  • Dialysis fluid is added, which then leaves the dialyser 303 as a so-called dialysate through a line / dialysate line / liquid line 307.
  • the dialysate is fed via a dialysate line / liquid line 308 into a drain, not shown in detail.
  • the dialysate is therefore a liquid which is in contact with a liquid from the body, the blood, via the dialyzer 303 and its membrane.
  • a connectable removal device 309a, 309b can be used as a sample container in order to examine the dialysate.
  • a suitable sampling point is located, for example, in line 307. If such a sampling point is not available, the sampling device 309b can also be used directly at the machine exit in order to take and examine a dialysate sample.
  • Line 306 represents another tapping point. In the area Acute and peritoneal dialysis bags are often used
  • these bags can also be equipped with test strips, sample containers or
  • test strip In the case of cloudy liquids such as blood in particular, it is within the scope of the invention to separate the test strip from the liquid to be examined with a semipermeable membrane.
  • the pores of this membrane are large enough to allow the analyte or analytes to pass through, but at the same time small enough to be disruptive
  • sample containers 8a, 8b, 8c can in the
  • Embodiment of Figure 5 be prefilled with a preferably isotonic solution, so that an analyte, if present in the liquid in the liquid space 2, then passes through the membrane by means of diffusion.
  • a syringe-like removal device is used as in the embodiment of FIG. 7, a passage in the syringe cylinder 11 being provided with a membrane, a pre-filling is not necessary, since the piston 12 does not diffuse, but convection is the driving force due to the piston 12 moving in the syringe cylinder 11 is to convey any substance to the test strip.
  • FIG. 9 shows a modified embodiment of the liquid system 1, which essentially corresponds to the embodiment according to FIG. 1, so that reference is made to the relevant description and only deviations are described below.
  • the test strip 100 is in a bypass 13. Accordingly, a test strip 100 can be arranged in the bypass 13, which is designed here as a bypass line.
  • the bypass 13 is interchangeable with the liquid line 4, but can also on any other
  • bypass 13 with the test strip 100 can be exchanged in a particularly simple manner without the catheter 6 having to be separated from the collecting bag 1.
  • the bypass 13 is connected to an integrated test strip 100 preferably via penetration of a connection point 14 which has a self-sealing membrane or a valve.

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Abstract

L'invention concerne un système pour analyser des fluides d'origine corporelle, comprenant un volume parcouru par le fluide, en particulier une conduite de fluide (4, 5, 6, 306, 307, 308) et/ou un volume de stockage de fluide (1, 2), et une unité de détection (100, 200) qui est intégrée dans le système et qui est reliée ou peut être reliée audit volume, conçue pour déceler au moins un analyte dans le fluide et/ou au moins un paramètre du fluide, cette unité de détection comportant une bande de test (100, 200) comprenant au moins un champ de test (101 - 111) qui colore le fluide, en présence d'un analyte à détecter ou en fonction d'un paramètre à détecter du fluide.
EP19769417.7A 2018-09-10 2019-09-10 Système pour analyser des fluides d'origine corporelle ou des fluides en contact avec le corps Pending EP3849625A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102018122024.3A DE102018122024A1 (de) 2018-09-10 2018-09-10 System zur Analyse von aus dem Körper stammenden Flüssigkeiten oder mit ihnen in Kontakt stehenden Flüssigkeiten
PCT/EP2019/074115 WO2020053212A1 (fr) 2018-09-10 2019-09-10 Système pour analyser des fluides d'origine corporelle ou des fluides en contact avec le corps

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EP3849625A1 true EP3849625A1 (fr) 2021-07-21

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EP (1) EP3849625A1 (fr)
DE (1) DE102018122024A1 (fr)
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CN111481396A (zh) * 2020-05-08 2020-08-04 李巧龄 一种宫腔镜及液体收集的微创混合手术室设备

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US4846005A (en) * 1986-12-12 1989-07-11 Baxter International Inc. Set with attachable sample cell
US5577499A (en) * 1994-10-03 1996-11-26 Teves; Leonides Y. Blood analyzer
US20100120073A1 (en) * 2007-05-08 2010-05-13 Superior Medical Llc Methods and devices for detecting organisms causing urinary tract infections
US20130172781A1 (en) * 2011-10-21 2013-07-04 Dale Medical Products, Inc. pH INDICATOR MODULE FOR GASTRIC TUBES
WO2016176603A1 (fr) * 2015-04-30 2016-11-03 Digisense Ltd. Capteur
WO2018058077A1 (fr) * 2016-09-23 2018-03-29 University Of Florida Research Foundation, Inc. Système et procédé de détection bactérienne pour cathéter urinaire

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